Issue link: https://www.e-digitaleditions.com/i/1351840
14 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 P h a r mTe c h . c o m Operations from uncontrolled to controlled and then to clas- sified areas. Lastly, the shipping containers must also serve to protect the packaged garment from damage during handling and not contaminate the packaged garment during opening or distri- bution into the gown rooms. Cardboard boxes pose contamination risk Cardboard boxes pose a severe risk to contami- nation control. The cardboard materials can transfer mold, fibers, and insects into a facility or onto the products they contain. The contain- ers for transfer must be assessed for cleanability, potential risk they could pose to the facility, as well as to the facility's cleanrooms and controlled environments. This risk increases when the boxes are transported by common carriers or non-ded- icated transport companies. Additionally, regulatory agencies recommend the use of plastic or synthetic pallets to prevent the transfer of contamination that is associated with use of wood pallets and shipping materials. The cleanroom user must assess these risks. Even if two different cleanroom garments are equal in design, specification, and cleanliness, if the packaging that contains one of them has not been carefully designed, or the process for transferring the garments to different parts of the facility has not been carefully controlled, it will still lead to cleanroom contamination. A number of established tests are used to mea- sure particles in and on garments and evaluate the cleanliness of the final packaged cleanroom garments (3–5). These tests (i.e., the American Society of Testing and Materials [ASTM] F51 and the Helmke Drum test) establish specific cleanli- ness limits for use in various classes of cleanroom. However, these limits only refer to a clean unworn garment and do not address the performance of a garment that is currently being used. The cleanroom garment system is designed to protect the product, process, and cleanroom envi- ronment from operator-generated contamination. Despite special training designed to maximize the level of protection afforded by cleanroom garments, operators can still unknowingly con- taminate the cleanroom. When this happens, it's crucial to ask whether the problem was caused by vulnerabilities in the garment system, or person- nel training issues. Particulate filtering tests Data have been published on cleanroom garments, using standardized methods to assess their ability to filter out particulates. The required tests subject cleanroom garment fabric swatches to an aerosol suspension of particles. However, some of the pub- lished data were generated decades ago and are based on first-generation polyester taffeta garments, which have a mean pore size of up to 80 microm- eters in diameter. In the tests described in this article, polyester gar- ments were used that were made of StarShield ESD, a fabric that consists of 99% high density polyester with 1% carbon fiber (used as an antistatic) and a mean pore size of 3–10 micrometers. This fabric can be cleaned to the highest cleanliness categories specified by the laboratory test methods. The goal of this testing was to assess the impact of the garment on the cleanroom during operations and to evaluate garment types under dynamic con- ditions. Two critical questions were asked: • Can you test a garment in use? • Can you perform the testing real time dur-